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Life Threatening? No
Write-up: Information has been received from a physician on 20-OCT-2011. Case reported as serious (hospitalization and disability). Case medically confirmed. A 17-year-old female patient had received the third dose of GARDASIL (batch number not reported) on an unspecified date. One month after vaccination, the patient experienced myalgia, shortness of breath and had no more strength. At the time of reporting, the outcome was not provided. To be noted that the patient was followed by a cardiologist, and that according to the patient''s mother, the events were due to the vaccine. Follow-up information received on 24-JAN-2012: The patient was 14-year-old at the time of the events instead of 17 as previously reported. The patient had received the first dose of GARDASIL (batch number not reported) on 01-MAR-2011, the second dose (batch number NM23050) on 27-MAY-2011, and the third dose (batch number NM45890) on 29-AUG-2011. She had concomitantly received NEISVAC-C (other manufacturer, batch number VN914776) on 18-JUN-2011. Starting in the middle of September-2011, the patient was found severe asthenia, concentration impaired, appetite disorder, menstrual disorder and movements disorder. The patient also experienced narcolepsy accompanies by fine movements disorder. The disorders rapidly deteriorated. The patient was referred to a cardiologist dud to chest oppression and shortness of breath, and to a rheumatologist due to diffuse joint pain. She was subsequently hospitalized. Consultation at the cardiologist on 19-OCT-2011: The patient who used to practice high sporting activity up to the last summer presented since then severe asthenia with a need for prolonged sleep period furthermore, she also presented with malaises, some of them occurring just after practice sport with a sensation of slow heart beat which necessitated that she sat down, then followed by lipothymia without loss of consciousness. Other malaises occurred when she was in a sitting position, during the meal, or even lying down. It was difficult to assess whether she had lost consciousness. There was no familial history of heart disease, in particular no history of rhythmology anomaly which could have led to early serious events. Blood pressure was 10.5-6, hear sounds were regular, there was no sound or pathological add- on murmur. Distal pulse could be heard, there was no cervical murmur, lung auscultation was correct. Electrocardiogram showed sinusal rhythm 94/mm, PR interval 0-16, QRS axis superior to 40, supple repolarization, Q-T interval 0-28 for a theorical basis of 0-31. Carotid sinus massage did not show any hyper reflexivity. Echodoppler was reassuring with a good global and segmentary contractility and no stigma of pulmonary arterial hypertension, no shunt, no cavitary dilatation particularly left artrial. Doppler tissue imaging screening showed a mitral annulus normal. To be noted that the patient had experienced cutaneous hyper reactivity consequently to mosquito bites. The cardiologist suspected a possible tick bite which could lead to search for arguments suggestive of Lyme disease. 24h-ECG Holter monitoring was recommended. Consultation at hospital on 17-NOV-2011: The patient used to practice piano, dancing and sailing. During the last summer she had practiced sailing and cycling in a sport summer camp. To be note that the patient had started to have her periods from 9 years old to 11 years old. She now had her periods since the age of 13 under treatment with DUPHASTON which had recently been interrupted. On examination she presented with malaises with sensation for cardiac arrest. She presented with 4 malaises apparently with no prodrome, accompanied by hypersomnia (the patient slept for approximately 1 hour). When she was seen by her family and friends circle, she was found to have a sensation of white and cold hands and sweating. There was no notion of aura before these malaises, no loss of urine and no tonic-clonic movements. But the patient presented with p
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